RESOURCES

Good Manufacturing Practice Facility (GMP)
Dr. Falanga’s laboratory has developed a GMP facility at Boston University School of Medicine (BUSM)

Infrastructure:

GMP_Falanga

 

Diagram of GMP facility in BUSM (R) Building

 

The GMP facility is located in the Rm. 209 of the R Building at Boston University Medical Center and comprised of three (3) primary spatial components including the actual GMP Lab (237 square feet), Ante Rm. (45 square feet) and the Vestibule (99 square feet).  Cells grown in the GMP facility can be administered to patients in the interconnecting Clinical Research Center, thus avoiding temperature changes and other variable that could affect cell viability. Air pressurization is scheduled positive from the GMP Lab to Ante Rm. and positive from the Ante Rm. to Vestibule (See above diagram ). The space is served with a dedicated Air Handling Unit (AHU-1) located in the vestibule which is provided with 100% outside air.  AHU1 includes a pre-filter bank with filtration rated at a minimum MERV rating 11.  Supply air HEPA filtration units are used in both the GMP Lab and Ante Rm, providing filtration efficiency of 99.99% on a 0.3 micron particle size.  The system also includes dedicated reheat and humidification, thus allowing for independent control of the space.  All systems including equipment alarming are connected to the existing building management system (BMS).  It should also be noted that redundant air pressure monitoring is being provided a) through the BMS with digital monitoring and pressure alarming and b) with onsite “visual” pressure monitoring devices which allow the onsite staff to immediately recognize any pressurization issues.  Doors to and from the Ante Rm. are interlocked to prevent both doors from being open at the same time, therefore allowing pressure relationships to be properly maintained.  All finish surfaces (including floors, ceiling, horizontal surfaces, etc.) are highly cleanable and resistant to primary cleaning agents.  Dropped ceilings are gasketed and perimeter demising partitions extend from the floor slab to the underside of the structural deck above.  These partitions are completely sealed as are any penetrations.  Casework surfaces are stainless steel.  Electrical conduit is also sealed.  All maintainable equipment (i.e. humidifiers, reheats, etc.) with the exception of the aforementioned HEPA Filter Air Diffusers, are located above ceiling “outside” the suite, to allow for scheduled preventative maintenance to be completed without having to enter the secured spaces.  The creation of the Vestibule also allows for the space to be serviced (i.e. changing of lab gas tanks, etc.) without delivery and maintenance staff having to enter the Ante Rm. or Lab. A monitoring system records pressures and temperatures within the facility and equipment. The facility has a computer at entry point to facilitate logging of activity, materials, environmental monitoring, etc.

Diagram below is an example of a GMP facility that was developed by Dr. Falanga and his research team:

gmp_facility
GMP facility flow (A to F) into “clean” Rm (F)